Medical device electronics
Where the documentation is part of the deliverable, not an afterthought — and where a design decision you cannot evidence is a design decision you did not make.
Evidence
What we can substantiate
Everything below is work we have actually done, described at a level that respects the client’s confidentiality. If you need detail, ask under NDA.
- IEC 60601-1 class design Peritoneal dialysis equipment electronics
- Isolation and clearance Creepage and clearance to patient-contact requirements
- Design traceability Requirements tables, review packages, client-facing design records
- Component grading Selection and derating appropriate to the risk class
Common questions
Straight answers
Do you certify the device?
No — certification runs through a notified body, and any design house telling you otherwise is overselling. What we do is make sure the electronics do not make certification harder than it needs to be: isolation and clearance right from the schematic, component choices you can justify, and design records that answer an auditor rather than provoking more questions.
What documentation comes with the design?
Requirements traceability tables, design rationale for the decisions that matter, review packages, and a full manufacturing dataset. In this sector the documentation is a deliverable in its own right, so it is scoped and priced as one.
Got a board to design — or one that won’t boot?
You talk to the engineer who would do the work. Reply within one business day, and we’ll sign your NDA before you go into detail.